Bayonet injection needles recalled after showing elevated cytotoxicity in testing
Bayonet Luer-Lock injection needles, models 50-353-23 and 50-345-23, are recalled because affected product showed elevated cytotoxicity values, which may present a risk of intolerance or allergic reaction.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice describes a risk of intolerance or allergic reaction and reports no injuries.
Plain-English summary
Bayonet Luer-Lock injection needles are being recalled in two models: model 50-353-23, working length 25 cm and total length 31 cm, UDI-DI 04250381858806, lot (0)2241239; and model 50-345-23, working length 24 cm and total length 31 cm, UDI-DI 04250381858813. Both are supplied non-sterile. Distribution was in California, Connecticut, Missouri and Ohio.
The affected product showed elevated cytotoxicity values. Use of the affected injection needles may present a risk of an intolerance reaction or an allergic reaction. The FDA classified the action as Class II.
Hospitals and clinics holding these model and lot numbers should quarantine affected stock and follow the manufacturer's instructions for return.
The recalled product
- Product
- Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile
- Manufacturer
- Spiggle & Theis Mt Gmbh
- Hazard
- cytotoxicity
- allergic-reaction-risk
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 1. Model No 50-353-23
- UDI-DI 04250381858806
- LOT (0)2241239 2. Model No 50-345-23
- UDI-DI 04250381858813
- LOT 2230438
- LOT 2240251
Distribution
Distributed nationwide across the United States.
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